Important Risk Information

As with any medical procedure, there are risks and complications associated with the bronchoscopy procedure as well as with the PneumRx Coil treatment. Additionally, the PneumRx Coils may not be available in your geographic area.

Possible Risks

Risks of bronchoscopy include:

The possibility of fever, bleeding, spasm, irregular heartbeat, shortness of breath, infection, pneumonia, air leaks from the lungs, which may or may not require a chest tube, collapse of part of the lung, or temporary loss of consciousness. There is a possibility of puncturing the airway when a bronchoscope is inserted.

The possibility that you may experience wheezing, coughing with or without the presence of a small of amount of blood, or shortness of breath during the first few days after each procedure.

There is a possibility that you will experience a temporary drop in the amount of oxygen in your blood following the procedure.

The use of the Coil may be linked to possible risks, in addition to the possible complications of bronchoscopy:

Difficulty with or impossibility of implanting the Coil; accidental implantation of the Coil into the wrong location; pneumonia; or complications, which could require surgical removal of the Coil. Unexpected complications or unforeseeable risks that are not currently known could occur. If complications occur, your doctor may decide that emergency surgery or another type of care is required to treat the condition. Emergency surgeries are linked with higher degrees of risk than scheduled operations.

If the Coil needs to be removed by your Doctor, this would require a similar medical procedure as was performed to implant the Coil. Note that Coil removal has only been tested out to two months post implantation.

Since you have emphysema, undergoing procedures in your lungs (including bronchoscopy alone) could result in severe bronchospasm, collapse of part of the lungs, or death.

The Coil has not been tested for potential risks associated with pregnancy. Coil treatment may involve risks to you (or to the embryo or fetus, if you become pregnant), which are currently unforeseeable. You should discuss reproductive risks with your Doctor.

Alternative Procedures

There are other medical treatments available.

There are a variety of therapies available to treat the symptoms of emphysema. Patient should be on optimal medical management (taking prescribed combinations of available drugs) smoking cessation and exercise programs, as well as supplemental oxygen if needed, before considering endoscopic or surgical treatments.

Two surgical procedures are: Lung Transplantation Surgery and Lung Volume Reduction Surgery (LVRS). Lung transplant surgery is an unrealistic option for many emphysema patients because there may be a shortage of available donor lungs and it is difficult to meet the selection criteria to receive a donor lung(s). LVRS is major surgery performed by a thoracic surgeon in an operating room. While one is under heavy anesthesia, surgery to remove a large portion of your lung tissue is performed, resulting in a lengthy hospital stay and post-operative recovery.

Your doctor may be able to tell you more about the potential benefits and risks of alternative therapies and interventions.